System and method for determining ventilator leakage during stable periods within a breath

ABSTRACT

This disclosure describes systems and methods for compensating for leaks in a ventilation system based on data obtained during periods within a breath in which the patient is neither inhaling nor exhaling. The methods and systems described herein more accurately and quickly identify changes in leakage. This information is then to estimate leakage later in the same breath or in subsequent breaths to calculate a more accurate estimate of instantaneous leakage based on current conditions. The estimated leakage is then used to compensate for the leak flow rates, reduce the patient&#39;s work of breathing and increase the patient&#39;s comfort (patient-ventilator breath phase transition synchrony).

BACKGROUND

The present description pertains to ventilator devices used to providebreathing assistance. Modern ventilator technologies commonly employpositive pressure to assist patient ventilation. For example, afterdetermining a patient-initiated or timed trigger, the ventilatordelivers a specified gas mixture into an inhalation airway connected tothe patient to track a specified desired pressure or flow trajectory,causing or assisting the patient's lungs to fill. Upon reaching the endof the inspiration, the added support is removed and the patient isallowed to passively exhale and the ventilator controls the gas flowthrough the system to maintain a designated airway pressure level (PEEP)during the exhalation phase. Other types of ventilators arenon-triggered, and mandate a specified breathing pattern regardless ofpatient effort.

Modern ventilators typically include microprocessors or othercontrollers that employ various control schemes. These control schemesare used to command a pneumatic system (e.g., valves) that regulates theflow rates of breathing gases to and from the patient. Closed-loopcontrol is often employed, using data from pressure/flow sensors.

Many therapeutic settings involve the potential for leaks occurring atvarious locations on the ventilator device. The magnitude of these leakscan vary from setting to setting, and/or dynamically within a particularsetting, dependent upon a host of variables. Leaks can impair triggering(transition into inhalation phase) and cycling (transition intoexhalation phase) of the ventilator; and thus cause problems withpatient-device synchrony; undesirably increase patient breathing work;degrade advisory information available to treatment providers; and/orotherwise comprise the desired respiratory therapy.

Determining Ventilator Leakage from Data Taken During a Stable Periodwithin a Breath

This disclosure describes systems and methods for compensating for leaksin a ventilation system based on data obtained during periods within abreath in which the patient is neither inhaling nor exhaling. Themethods and systems described herein more accurately and quicklyidentify changes in leakage. This information is then to estimateleakage later in the same breath or in subsequent breaths to calculate amore accurate estimate of instantaneous leakage based on currentconditions. The estimated leakage is then used to compensate for theleak flow rates, reduce the patient's work of breathing and increase thepatient's comfort (patient-ventilator breath phase transitionsynchrony). Without the improvements provided by the disclosed methodsand systems, changes in the leak conditions during a breath may not beidentified and/or accurately characterized until the following breath orlater.

In part, this disclosure describes a method for identifying leakage in arespiratory gas supply system. In the method, data indicative of atleast one of pressure and flow in the respiratory gas supply system ismonitored during the delivery of respiratory gas to a patient. Themethod includes identifying that the data meet at least one stabilitycriterion indicating that pressure and flow conditions have been stablefor a period of time within a breath. These stability criteria areselected to identify stable periods within a breath in which the patientis neither inhaling nor exhaling. Upon identification of a stableperiod, the method calculates leakage information based at least in parton the data taken during the period of time within the breath. Thisleakage information may take the form of one or more orifice constants,leak conductances, leak factors, exponents, or other leakcharacteristics as required by the leakage model utilized by theventilator to estimate instantaneous leakage from the current status(e.g., pressure or flow) of the ventilator. The method then uses theleakage information to determine a leakage rate in subsequentcalculations performed after the stable period. This may includeestimating an instantaneous leakage after the period of time based atleast in part on the leakage information derived from data taken duringthe stable period.

This disclosure also describes a respiratory gas supply system thatidentifies stable periods within a breath and derives leakageinformation for use later in the same breath or in subsequent breaths inestimating instantaneous leakage. The system includes a pressuregenerating system capable of controlling the flow of breathing gasthrough a patient circuit and a patient interface to a patient, a stableperiod identification module that identifies a stable period within abreath, and a leak compensation module that calculates leakageinformation using data obtained during the stable period identified bythe stable period identification module and that calculates, duringsubsequent stable and unstable periods within the breath or a laterbreath, an instantaneous leakage rate based on the leakage information.

This disclosure also describes another method for determining leakagefrom a respiratory gas supply system providing respiratory gas to abreathing patient. The method includes identifying at least one stableperiod within a patient breath and calculating leakage information basedon pressure and flow data obtained during the at least one stableperiod. The method also, at times subsequent to the stable period,estimates the leakage from the respiratory gas supply system based onthe leakage information calculated from the data obtained during the atleast one stable period and the current data.

These and various other features as well as advantages whichcharacterize the systems and methods described herein will be apparentfrom a reading of the following detailed description and a review of theassociated drawings. Additional features are set forth in thedescription which follows, and in part will be apparent from thedescription, or may be learned by practice of the technology. Thebenefits and features of the technology will be realized and attained bythe structure particularly pointed out in the written description andclaims hereof as well as the appended drawings.

It is to be understood that both the foregoing general description andthe following detailed description are exemplary and explanatory and areintended to provide further explanation of the invention as claimed.

BRIEF DESCRIPTION OF THE DRAWINGS

The following drawing figures, which form a part of this application,are illustrative of described technology and are not meant to limit thescope of the invention as claimed in any manner, which scope shall bebased on the claims appended hereto.

FIG. 1 illustrates an embodiment of a ventilator connected to a humanpatient.

FIG. 2 schematically depicts exemplary systems and methods of ventilatorcontrol.

FIG. 3 illustrates an embodiment of a method for identifying the leakagefrom a ventilation tubing system of a respiratory gas supply system.

FIG. 4 illustrates another embodiment of a method for identifying theleakage from a ventilation tubing system of a respiratory gas supplysystem.

FIG. 5 illustrates a functional block diagram of modules and othercomponents that may be used in an embodiment of ventilator thatcompensates for leaks.

DETAILED DESCRIPTION

Although the techniques introduced above and discussed in detail belowmay be implemented for a variety of medical devices, the presentdisclosure will discuss the implementation of these techniques in thecontext of a medical ventilator for use in providing ventilation supportto a human patient. The reader will understand that the technologydescribed in the context of a medical ventilator for human patientscould be adapted for use with other systems such as ventilators fornon-human patients and general gas transport systems in which leaks maycause a degradation of performance.

As a threshold issue, the terms “leakage” and “leak” shall be used torefer to only the inadvertent escape of gas from unknown locations inventilation system and does not include any measured or knownintentional discharges of gas (such as through an exhaust port, reliefvalve or an expiratory limb). A leakage may be expressed as a rate(flow) or a volume depending on the situation.

FIG. 1 illustrates an embodiment of a respiratory gas supply system inthe form of a ventilator 20 connected to a human patient 24. Ventilator20 includes a pneumatic system 22 (also referred to as a pressuregenerating system 22) for circulating breathing gases to and frompatient 24 via the ventilation tubing system 26, which couples thepatient to the pneumatic system via physical patient interface 28 andventilator circuit 30. Ventilator circuit 30 could be a dual-limbcircuit (as shown) for carrying gas to and from the patient or asingle-limb system that delivers breathing gas to the patient afterwhich it is discharged directly to the atmosphere without being returnedto the pneumatic system 22. In a dual-limb embodiment as shown, a wyefitting 36 may be provided as shown to couple the patient interface 28to the inspiratory limb 32 and the expiratory limb 34 of the circuit 30.Exhaled gas is discharged from the expiratory limb 34 through theventilator 20 which discharge of gas may be both monitored andcontrolled by the ventilator 20 as part of the delivery of gas to thepatient.

The present systems and methods have proved particularly advantageous innoninvasive settings, such as with facial breathing masks, as thosesettings typically are more susceptible to leaks. However, leaks dooccur in a variety of settings, and the present description contemplatesthat the patient interface may be invasive or non-invasive, and of anyconfiguration suitable for communicating a flow of breathing gas fromthe patient circuit to an airway of the patient. Examples of suitablepatient interface devices include a nasal mask, nasal/oral mask (whichis shown in FIG. 1), nasal prong, full-face mask, tracheal tube,endotracheal tube, nasal pillow, etc.

Pneumatic system 22 may be configured in a variety of ways. In thepresent example, system 22 includes an expiratory module 40 coupled withan expiratory limb 34 and an inspiratory module 42 coupled with aninspiratory limb 32. Compressor 44 or another source(s) of pressurizedgas (e.g., air and oxygen) is coupled with inspiratory module 42 toprovide a gas source for ventilatory support via inspiratory limb 32.

The pneumatic system may include a variety of other components,including sources for pressurized air and/or oxygen, mixing modules,valves, sensors, tubing, accumulators, filters, etc. Controller 50 isoperatively coupled with pneumatic system 22, signal measurement andacquisition systems, and an operator interface 52 may be provided toenable an operator to interact with the ventilator (e.g., changeventilator settings, select operational modes, view monitoredparameters, etc.). Controller 50 may include memory 54, one or moreprocessors 56, storage 58, and/or other components of the type commonlyfound in command and control computing devices.

The memory 54 is computer-readable storage media that stores softwarethat is executed by the processor 56 and which controls the operation ofthe ventilator 20. In an embodiment, the memory 54 comprises one or moresolid-state storage devices such as flash memory chips. In analternative embodiment, the memory 54 may be mass storage connected tothe processor 56 through a mass storage controller (not shown) and acommunications bus (not shown). Although the description ofcomputer-readable media contained herein refers to a solid-statestorage, it should be appreciated by those skilled in the art thatcomputer-readable storage media can be any available media that can beaccessed by the processor 56. Computer-readable storage media includesvolatile and non-volatile, removable and non-removable media implementedin any method or technology for storage of information such ascomputer-readable instructions, data structures, program modules orother data. Computer-readable storage media includes, but is not limitedto, RAM, ROM, EPROM, EEPROM, flash memory or other solid state memorytechnology, CD-ROM, DVD, or other optical storage, magnetic cassettes,magnetic tape, magnetic disk storage or other magnetic storage devices,or any other medium which can be used to store the desired informationand which can be accessed by the computer.

As described in more detail below, controller 50 issues commands topneumatic system 22 in order to control the breathing assistanceprovided to the patient by the ventilator. The specific commands may bebased on inputs received from patient 24, pneumatic system 22 andsensors, operator interface 52 and/or other components of theventilator. In the depicted example, operator interface includes adisplay 59 that is touch-sensitive, enabling the display to serve bothas an input and output device.

FIG. 2 schematically depicts exemplary systems and methods of ventilatorcontrol. As shown, controller 50 issues control commands 60 to drivepneumatic system 22 and thereby circulate breathing gas to and frompatient 24. The depicted schematic interaction between pneumatic system22 and patient 24 may be viewed in terms of pressure and/or flow“signals.” For example, signal 62 may be an increased pressure which isapplied to the patient via inspiratory limb 32. Control commands 60 arebased upon inputs received at controller 50 which may include, amongother things, inputs from operator interface 52, and feedback frompneumatic system 22 (e.g., from pressure/flow sensors) and/or sensedfrom patient 24.

In many cases, it may be desirable to establish a baseline pressureand/or flow trajectory for a given respiratory therapy session. Thevolume of breathing gas delivered to the patient's lung (L₁) and thevolume of the gas exhaled by the patient (L₂) are measured ordetermined, and the measured or predicted/estimated leaks are accountedfor to ensure accurate delivery and data reporting and monitoring.Accordingly, the more accurate the leak estimation, the better thebaseline calculation of delivered and exhaled volume as well as eventdetection (triggering and cycling phase transitions).

When modeling the delivery of gas to and from a patient 24 via aclosed-circuit ventilator, one simple assumption is that compliance ofthe ventilator circuit 30 is fixed and that all gas injected into theventilator circuit 30 that does not exit the circuit 30 via theexpiratory limb 34 fills the circuit as well as the patient's lungs andcauses an increase in pressure, As gas is injected (L_(t)), the lungresponds to the increased gas pressure in the circuit 30 by expanding.The amount the lung expands is proportional to the lung compliance andis defined as a function of gas pressure differential (Compliance=volumedelivered/pressure difference).

Errors may be introduced due to leaks in the system. For example, in aperfect dual-limb system the difference in gas input into the system andgas exiting the system at any point in time is the instantaneous lungflow of the patient. However, if this method is used to calculate lungflow when there is, in actuality, some gas that is unknowingly leakingout the instantaneous lung flow calculation will be incorrect. Lung flowcalculations may be used for many different purposes such assynchronizing the operation of the ventilatory support provided by theventilator 20 with a patient's actual breathing. In order to improve theoverall operation of the ventilator, then, it is desirable to, wherepossible, identify and account for any leaks in the system that mayaffect the lung flow calculation.

Leaks may occur at any point in the ventilation tubing system 26. Theterm ventilation tubing system 26 is used herein to describe theventilator circuit 30, any equipment attached to or used in theventilator circuit 30 such as water traps, monitors, drug deliverydevices, etc. (not shown), and the patient interface 28. Depending onthe embodiment, this may include some equipment contained in theinspiration module 42 and/or the expiration module 40. When referring toleaks in or from the ventilation tubing system 26, such leaks includeleaks within the tubing system 26 and leaks where the tubing system 26connects to the pressure generator 22 or the patient 24. Thus, leaksfrom the ventilation tubing system 26 include leaks from the ventilatorcircuit 30, leaks from the patient interface 28 (e.g., masks may beprovided with holes or other pressure relief devices through which someleakage may occur), leaks from the points of connection betweencomponents in the tubing system 26 (e.g., due to a poor connectionbetween the patient interface 28 and the circuit 30), and leaks fromwhere the patient interface 28 connects to the patient 24 (e.g., leaksaround the edges of a mask due to a poor fit or patient movement).

FIG. 3 illustrates an embodiment of a method for identifying the leakagefrom a ventilation tubing system of a respiratory gas supply system. Inthe embodiment shown, a ventilator such any of those described above isdelivering gas to a patient as illustrated by the respiratory gasdelivery operation 302. The patient may be initiating breaths on his/herown (i.e., actively breathing) or the delivery of gas may be completelycontrolled by the ventilator so that respiratory gas is forced into andout of the lungs of the patient without any action on the patient'spart.

In addition to delivering gas, the method 300 includes a monitoringoperation 304 in which data on the pressure, flow and other operationalparameters are gathered while the ventilator is delivering gas.Monitoring refers to taking measurements or otherwise obtaining dataindicative of the operational condition of the ventilator (e.g.,pressure or flow) at one or more locations. For example, in a dual-limbventilator embodiment the pressure and flow in both the inspiratory limband the expiratory limb may be recorded by the monitoring operation 304.In an embodiment in which a sensor or sensors are provided at a wye orthe patient interface, the monitoring operation 304 may includeobtaining data from these sensors.

The monitoring operation 304 may include periodically or occasionallyrequesting or receiving data from a sensor or other data source. Forexample, in a digital system monitoring may be performed by gatheringdata from each sensor every time the sensor is polled by theventilator's control system or every computational cycle in which a dataanalysis routine is performed. In one such embodiment, monitoringincludes obtaining data from all sensors every computational cycle).Monitoring may also be performed continuously such as in an analogsystem in which analog signals from sensors are continuously feed intocomparators or other analog components for evaluation.

As part of the monitoring operation 304, the data are evaluated in orderto identify stable periods of operation in which the operationalconditions such as pressure and flow within the ventilation tubingsystem are relatively constant and indicative of a period during whichthe patient is neither breathing in nor breathing out significantly.Such stable periods, for example, may appear at the end of an inhalationjust prior to the patient beginning exhalation, at the end of anexhalation prior to the patient initiating the next inhalation and attimes when a patient is, consciously or unconsciously, holding his/herbreath.

In an embodiment, stable periods are identified by comparing the dataobtained by the monitoring operation 304 to one or more predeterminedstability criteria, illustrated by the stable period determinationoperation 306. The comparison may include comparing data from a fixed“window” or period of time to the stability criteria. For example, in anembodiment, a fixed window (i.e., a window of 50 milliseconds (ms) ofdata or of ten consecutive measurement obtained from the sensors) of themost recent data may be compared to the stability criteria.

The stability criteria are selected specifically to identify such stableperiods during which the patient is neither breathing in nor breathingout significantly. In an embodiment, the stability criteria may includestatic criteria (e.g., a predetermined threshold that remains fixedbased on operator selected settings such as a positive end expiratorypressure (PEEP) level) and dynamic criteria that must be recalculatedbased on the current conditions as indicated by the data itself (e.g., aflow threshold that is a function of the amount of flow delivered up tothat point in time). In addition, different stability criteria may beused depending on whether the current breath phrase is inhalation orexhalation.

Examples of stability criteria include a) a pressure based criterionsuch as a requirement that the average pressure during the window beingevaluated is greater than a minimum pressure threshold or less than amaximum pressure threshold in which the threshold may be a staticpressure based on the current ventilator settings or a dynamicallygenerated pressure threshold based on current data; b) a pressurevariation criterion identifying a maximum pressure variation within thewindow (e.g., a rate of change of pressure or a difference betweenpressure measurements within the window); c) a flow variation criterionidentifying a maximum flow variation within the window; d) a modecriterion that verifies that a specific type of patient circuit, patientinterface or ventilation mode is currently being used; e) a flowcriterion identifying a minimum or maximum flow threshold; f) a timecriterion identifying a minimum or maximum amount of time since somepredefined event such as since the start of the current inhalation orexhalation cycle; and g) a volume criterion identifying a specificvolume of gas that must have been inhaled or exhaled since the start ofthe current breath phase. As mentioned above, all of these criteria maybe static criteria (unchanging during a breath) or may be dynamiccriteria (that is criteria that recalculated based on current dataeither periodically or every time the stable period check is performed).Other types of criteria could also be used to identify stable periodsincluding criteria based on patient effort as determined by ancillaryequipment and criteria that are based on sensors other than pressure orflow sensors.

If the comparison of the data to the stability criteria indicates thatthe gas delivery by the ventilator does not meet the predeterminedstability criteria, the conditions in the current window are notconsidered stable enough to use in determining the current leakage ofthe system. In this case, the determination operation 306 branches to anestimate instantaneous leakage operation 310 in which the instantaneousleakage from the ventilation tubing system is calculated usingpreviously determined leakage information, that is leakage informationgathered prior to the comparison, such as during a previous breath, setof breaths or stable period.

The estimate instantaneous leakage operation 310 may calculate theinstantaneous leakage using any one (or more) of known leakage modelingtechniques. These include calculating an instantaneous leak using analgorithm that estimates instantaneous leakage based on the current (orinstantaneous) pressure within the system and some predetermined leakageinformation, such as a leak conductance, a leak factor or one or morehypothetical orifice constants. For example, in one embodiment, theinstantaneous leakage is modeled as a hypothetical rigid orifice inwhich the instantaneous leakage from the system is simply a function ofa predetermined orifice constant and the square root of theinstantaneous pressure. In another embodiment, a leak conductance may becalculated and the instantaneous leakage from the system is a functionof a predetermined conductance and the square root of the instantaneouspressure. In yet another embodiment, a leak factor may be calculated andthe instantaneous leakage from the system is a function of apredetermined leak factor and the instantaneous pressure or some otherparameter indicative of the current operation of the system. In yetanother embodiment, the instantaneous leakage may be modeled as a set ofdifferent hypothetical orifices each representing different aspects ofleakage (e.g., a rigid orifice of constant size and one or more dynamicorifices that change in size based on instantaneous pressure) in whichthe instantaneous leakage from the system is a function of thepredetermined orifice constant for each orifice and the instantaneouspressure. Any suitable leakage model may be used in the estimateinstantaneous leakage operation 310 now known or later developed.

However, if the comparison of the data to the stability criteriaindicates that the window of data meets the predetermined stabilitycriteria, the window is considered stable and the patient is assumed tonot be inhaling or exhaling. In this case, the determination operation306 branches to an update leakage information operation 308.

In the update leakage information operation 308, the data from the timeperiod of the stable window is used to generate leakage information fromwhich the instantaneous leakage may be determined. The type of leakageinformation generated is determined by the leakage model used in theestimate instantaneous leakage operation 310. As discussed above, anysuitable leakage model may be used in the estimate instantaneous leakageoperation 310 now known or later developed. However, it is presumed thateach leakage model will require some type of predetermined leakageinformation in order to estimate instantaneous leakage at any particularmoment from a current pressure measurement. This leakage information maytake the form of one or more orifice constants, leak conductances, leakfactors, exponents, or other leak characteristics as required by aleakage model.

The term leakage information, as used herein, refers to any suchpredetermined information that is later used in to estimateinstantaneous leakage from the system based on the current system'sconditions. The leakage information differs from prior art systems inthat it is calculated from data taken during a narrow window of timethat is entirely within a breath. In an embodiment, windows are limiteda fixed duration within either the exhalation or inhalation phase of abreath so that no window will span time within two phases. In analternative embodiment, depending on the stability criteria usedembodiments of the leakage determining systems and methods describedherein may or may not require identification of whether the patient isin an inhalation or exhalation phase. Note that because the onset ofeither phase of a breath will exhibit significant instability in thatthe pressure and/or flow will be changing, appropriate selection oflength of the window to be analyzed and the stability criteria willprevent the possibility that of a window being identified as stable whenit straddles two phases.

The update leakage information operation 308 uses some or all of thedata from the identified stable window of time to calculate new leakageinformation. This new leakage information may then be used instead ofthe previously calculated leakage information or may be used inconjunction with some or all of the previously calculated leakageinformation. For example, in an embodiment in which a multiple orificemodel is used to model the leakage from the ventilation tubing system,one or more of the orifice constants may be updated (i.e., changed basedon the data within the window) while other constants used in the modelmay be retained from earlier calculations.

In an embodiment, the update leakage information operation 308 mayupdate the leakage information to one or more default values based onthe data in the stable window instead of calculating new values from thedata. For example, if the data in the stable window indicates that theleakage during the time period of the stable window was very low, theleakage information may be set to some default minimum value. Likewise,if the data in the stable window indicates that the leakage during thetime period of the stable window was very high, the leakage informationmay be set to some default maximum value.

After the leakage information operation 308 has updated some or all ofthe leakage information based on the data from the stable window, in theembodiment shown the estimate instantaneous leakage information 310 isperformed. In an embodiment, this may be performed in the samecomputational cycle that the leakage information is updated.Alternatively, this may be performed in a later cycle, wherein thecurrent instantaneous leakage information is obtained from a differentmethod. For example, in a dual-limb ventilation system during a stableperiod the estimated instantaneous leakage may be discarded in favor ofthe direct measurement of the leakage, i.e., the difference between themeasured inflow into the inspiratory limb and the measured outflow outof the expiratory limb.

The method 300 also compensates the delivery of respiratory gas based onthe instantaneous leakage, as illustrated by the compensate operation312. As discussed above, this may include compensating a lung flowestimate for instantaneous leakage or changing the amount of gasdelivered to the inspiratory limb in order to compensate for theestimated instantaneous leakage. Other compensation actions may also beperformed.

The method 300 then repeats so that the ventilator is continuouslymonitoring the delivery of gas to identify stable periods within abreath phase and update the leakage information based on the data fromthose stable periods. In an embodiment, additional leakage informationmay be determined at specified points in the respiratory cycle. Forexample, in an embodiment leakage information may be determined at theend of every breath for use in the next breath. The method 300 may thenbe used in order to check the leakage information determined at the endof a breath. This embodiment is described in greater detail withreference to FIG. 4.

FIG. 4 illustrates another embodiment of a method for identifying theleakage from a ventilation tubing system of a respiratory gas supplysystem. In the embodiment shown, a ventilator such any of thosedescribed above is delivering gas to a patient. Again, the patient maybe initiating breaths on his/her own (i.e., actively breathing) or thedelivery of gas may be completely controlled by the ventilator so thatrespiratory gas is forced into and out of the lungs of the patientwithout any action on the patient's part.

In the method 400, at the beginning of each new breath, leakageinformation is calculated from data taken during one or more priorbreaths in a calculate leakage information operation 402. Unless changedby the later update leakage operation 418 (discussed below) this leakageinformation will be used in the estimate instantaneous leakage operation406 for the remainder of the breath; this will occur, for instance, ifno stable periods are identified during the breath.

In the embodiment shown, the remaining operations in the method 400,i.e., operations 404-422, are repeated until the next breath istriggered. During this time, the ventilator is providing ventilatorysupport to the patient as directed by a caregiver.

The method 400 includes obtaining the current flow and pressuremeasurements from the various sensors in the ventilator in an obtaindata operation 404.

An estimate instantaneous leakage operation 404 is then performed asdescribed above with reference to the estimate instantaneous leakageoperation 310 in FIG. 3. This operation 404 calculates an instantaneousleakage based on the current pressure measurements (and/or other datadepending on the leakage model used).

The ventilator then compensates for the estimated instantaneous leakagein a compensate operation 408 as described above with reference to thecompensate operation 312 in FIG. 3.

The method 400 also performs a comparison of the data obtained in theobtain data operation 404 as illustrated by the compare data operation410. The compare data operation 410 compares data from a recent windowof time in order to identify a stable period as described above withreference to FIG. 3. The comparison may include comparing a fixed windowof data to the stability criteria. For example, in an embodiment, afixed window (i.e., a window of 50 milliseconds (ms) of data or of tenconsecutive measurement obtained from the sensors) of the most recentdata including the current data may be compared to the stabilitycriteria.

If the compare data operation 410 determines that the window beinganalyzed is not sufficiently stable (i.e., it does not meet thepredetermined stability criteria) as determined by a first determinationoperation 412, the current leakage information is not updated andanother determination operation 420 is performed to determine if a newbreath should be triggered or not and the method 400 then repeats asshown.

If the compare data operation 410 determines that the window beinganalyzed contains data that are sufficiently stable (i.e., the data inthe window meet the predetermined stability criteria) as determined bythe first determination operation 412, operations 414-418 are performedto check the accuracy of the current leakage information to determine ifsome or all of that information should be updated based on the data inthe stable window.

The accuracy check includes a determine actual leakage operation 414 inwhich the actual leakage during the stable window is determined based onknown information and data obtained from the stable window. In adual-limb embodiment, this may include calculating the differencebetween the measured inflow into the inspiratory limb and the measuredoutflow from the expiratory limb. In a single-limb embodiment, this mayinclude calculating the difference between the measured inflow into theinspiratory limb and a measured or otherwise known exhaust(s) from thelimb and/or patient interface. For example, the exhaust from an exhaustport in a patient interface may be monitored or otherwise determinablebased on a known size or known features of the exhaust port and thecurrent conditions. The actual leakage may be an average leakage rateduring the window, a total leakage volume that leaked out during some orall of the window, or some other element of information that describesthe leakage during or within the stable window.

The actual leakage during the window is then compared in a secondcompare operation 416 to the estimated leakage previously determined inthe estimate leakage operation 406. If the actual leakage does notdiffer from the estimated leakage by more than a threshold amount, asillustrated by determination operation 417, the current leakageinformation is not updated and another determination operation 420 isperformed to determine if a new breath should be triggered or not.However, if the actual leakage differs from the estimated leakage bymore than a threshold amount an update leakage information operation 418is performed.

The update leakage information operation 418 updates some or all of theleakage information as described above with reference to the updateleakage information operation 308 in FIG. 3.

FIG. 5 illustrates a functional block diagram of modules and othercomponents that may be used in an embodiment of ventilator thatcompensates for leaks. In the embodiment shown, the ventilator 500includes pressure sensors 504 (two are shown placed at differentlocations in the system), flow sensors (one is shown), and a ventilatorcontrol system 502. The ventilator control system 502 controls theoperation of the ventilator and includes a plurality of modulesdescribed by their function. In the embodiment shown, the ventilatorcontrol system 502 includes a processor 508, memory 514 which mayinclude mass storage as described above, a leak compensation module 512incorporating at least one leak model such as that described incommonly-owned U.S. Provisional Application 61/041,070 herebyincorporated herein, a stable period identification module 516, apressure and flow control module 518, and a monitoring module 522. Theprocessor 508 and memory 514 have been discussed above. Each of theother modules will be discussed in turn below.

The main functions of the ventilator such as receiving and interpretingoperator inputs and changing pressure and flow of gas in the ventilatorcircuit are performed by the control module 518. In the context of themethods and systems described herein, the module 518 may perform one ormore actions upon the determination that a patient receiving therapy isinhaling or exhaling.

The current conditions in the ventilation system are monitored by themonitoring module 522. This module 522 collects the data generated bythe sensors 504, 506 and may also perform certain calculations on thedata to make the data more readily usable by other modules or mayprocess the current data and or previously acquired data or operatorinput to derive auxiliary parameters or attributes of interest. In anembodiment, the monitoring module 522 receives data and provides it toeach of the other modules in the ventilator control system 502 that needthe current pressure or flow data for the system.

The ventilator 500 further includes a stable period identificationmodule 516. The stable period identification module 516 analyzes dataobtained by the monitoring module 522 in order to identify periods ofstability within a breath during which the patient is neither inhalingnor exhaling. The methods discussed above describe various embodimentsfor identifying stable periods using dynamic and/or static stabilitycriteria. Other embodiments are also possible and any method that canaccurately identify a stable period may be used.

When a stable period is identified, this information is passed to theleak compensation module 512. The leak compensation module 512 may thenupdate the current leak information to leak information derived from thestable period. In an embodiment, the leak compensation module 512 mayfirst compare the actual leakage during the stable period to the amountof leakage estimated for the period using the current leakageinformation. The results of this comparison may then dictate whether andhow the current leakage information is updated by leakage informationcalculated from the data taken during the stable period.

In the embodiment shown, the current or instantaneous inelastic leak isalso calculated by the leak compensation module 512 using one or morepredetermined leakage models. The leak compensation module 512 mayestimate a new instantaneous flow or volume for each sampling periodusing data taken by the monitoring module 522. The estimatedinstantaneous leak may then be provided to any other module as needed.

In an embodiment, the leak compensation module 512 uses the two orificeleak compensation model described in U.S. Provisional Application61/041,070 which is provided as an attachment hereto and which forms apart of this application. In this embodiment, the leak compensationmodule 512 calculates leakage information that includes the orificeconstant K₁ which represents leakage through an orifice of fixed sizeand the orifice constant K₂ which represents a dynamic orifice thatchanges size in response to changes in pressure. After calculating theleakage information, the leak compensation module 512 then uses thefollowing equation to calculate instantaneous leakage at later points intime:

Instantaneous Leakage=K ₁ P ^(0.5) +K ₂ P ^(1.5)

in which P is the instantaneous pressure. During a stability check, ifit is determined that the leakage information should be changed, eitherthe K₁ or the K₂ or both constants may be changed.

In addition, in the embodiment shown the leak compensation module 512also is responsible for compensating for the estimated instantaneousleakage. This may include compensation the estimates of other parameterssuch as lung flow and may include providing information to the controlmodule 518 to change the pressure or flow of the delivery of gas to thepatient.

The system 500 illustrated will perform a dynamic compensation of lungflow based on the changing leak conditions of the ventilation system andthe instantaneous pressure and flow measurements. By identifying stableperiods within a breath from which accurate leakage information may bedetermined, the medical ventilator can more quickly, accurately andprecisely identify changes the leakage from the ventilation tubingsystem and control the delivery of gas to compensate for such changes inleakage.

It will be clear that the systems and methods described herein are welladapted to attain the ends and advantages mentioned as well as thoseinherent therein. Those skilled in the art will recognize that themethods and systems within this specification may be implemented in manymanners and as such is not to be limited by the foregoing exemplifiedembodiments and examples. In other words, functional elements beingperformed by a single or multiple components, in various combinations ofhardware and software, and individual functions can be distributed amongsoftware applications at either the client or server level. In thisregard, any number of the features of the different embodimentsdescribed herein may be combined into one single embodiment andalternate embodiments having fewer than or more than all of the featuresherein described are possible. For example, the various operations inthe embodiments of methods described above may be combined or reorderedas desired without deviating from the overall teaching of thisdisclosure.

While various embodiments have been described for purposes of thisdisclosure, various changes and modifications may be made which are wellwithin the scope of the present invention. For example, leak informationneed not be calculated in real time for immediate use in determininginstantaneous leakage. In an embodiment, leak information from one ormore stable periods during a breath phase may be calculated and/or usedafter that breath in calculating instantaneous leakage during one ormore subsequent breaths.

Numerous other changes may be made which will readily suggest themselvesto those skilled in the art and which are encompassed in the spirit ofthe disclosure and as defined in the appended claims.

1.-24. (canceled)
 25. A method for determining leakage in a respiratorygas supply system, the respiratory gas supply system having a controlleradapted for delivering a flow of respiratory gases to a breathingpatient, the method comprising: monitoring data indicative of at leastone of pressure or flow in the respiratory gas supply system;determining, by the controller, that the data indicative of at least oneof pressure or flow has been stable for a period of time within a breathof a patient; calculating leakage information based at least in part onthe data determined to be stable during the period of time within thebreath; determining, by the controller, a leakage rate after the periodof time based at least in part on the leakage information; and adjustingat least one of a pressure and a flow delivered to the patient based onthe determined leakage rate.
 26. The method of claim 25, whereindetermining that the data indicative of at least one of pressure or flowhas been stable for a period of time is based on a comparison to atleast one stability criterion.
 27. The method of claim 25, furthercomprising: displaying the leakage rate to a user on a display.
 28. Themethod of claim 25 wherein determining the leakage rate furthercomprises: determining an instantaneous leakage rate after the period oftime using at least the leakage information and a pressure measurementtaken after the period of time.
 29. The method of claim 25, whereindetermining the leakage rate further comprises: determining aninstantaneous leakage rate after the period of time using the leakageinformation and at least one current pressure measurement.
 30. Themethod of claim 25, further comprising: monitoring data indicative ofpressure at two different locations in a patient circuit of therespiratory gas supply system.
 31. The method of claim 25, furthercomprising: monitoring data indicative of flow at two differentlocations in a patient circuit of the respiratory gas supply system. 32.The method of claim 25, further comprising: monitoring data indicativeof at least one of pressure and flow at different locations in a patientcircuit of the respiratory gas supply system.
 33. The method of claim25, wherein determining that the data indicative of pressure has beenstable for a period of time within a breath of a patient comprises:calculating a first value indicative of a rate of change of pressureduring at least a portion of the period of time; comparing the firstvalue to a first stability criterion; and when the first value meets thefirst stability criterion, classifying the period of time as stable. 34.The method of claim 25, wherein determining that the data indicative offlow has been stable for a period of time within a breath of a patientcomprises: calculating a second value indicative of a rate of change offlow during at least a portion of the period of time; comparing thesecond value to a second stability criterion; and when the second valuemeets the second stability criterion, classifying the period of time asstable.
 35. The method of claim 25, wherein calculating the leakageinformation comprises: calculating at least one constant based on datataken during the period of time, wherein the constant relates pressureto leakage rate in the respiratory gas supply system.
 36. The method ofclaim 25, wherein calculating the leakage information comprises:calculating a first orifice constant representing the relationshipbetween leakage flow through a hypothetical orifice and pressure in therespiratory gas supply system based on data taken during the period oftime.
 37. The method of claim 25, wherein determining that the dataindicative of at least one of pressure or flow has been stable for aperiod of time further comprises: periodically analyzing, whileproviding therapy to the breathing patient, a window of the data,wherein the window comprises recently monitored data, and wherein theperiodic analyzing is performed to determine whether the window of thedata meets at least one stability criterion.
 38. A respiratory gassupply system comprising: a pressure generating system configured tocontrol flow of breathing gases through a patient circuit and a patientinterface to a patient; and a computer controller communicativelycoupled to the pressure generating system for adjusting the flow ofbreathing gases delivered to the patient, the computer controllerconfigured to: identify a stable period within at least one of aninhalation phase and an exhalation phase of a breath; calculate leakageinformation using data obtained during the stable period; calculate,during at least one unstable period within the breath or a later breath,an instantaneous leakage rate based on the leakage information; andadjust at least one of a pressure and a flow delivered to the patientbased on the instantaneous leakage rate.
 39. The respiratory gas supplysystem of claim 38, wherein identifying the stable period comprisescomparing a window of recent pressure or flow data to one or morestability criteria during an inhalation phase.
 40. The respiratory gassupply system of claim 39, wherein the one or more stability criteriainclude at least one of: a first criterion identifying a minimumpressure, a second criterion identifying a maximum pressure variationwithin the window, a third criterion identifying a maximum flowvariation within the window, or a fourth criterion based on a patientcircuit type.
 41. The respiratory gas supply system of claim 38, whereinidentifying the stable period comprises comparing a window of recentpressure or flow data to one or more stability criteria during anexhalation phase.
 42. The respiratory gas supply system of claim 41,wherein the one or more stability criteria include at least one of: afifth criterion identifying a pressure threshold, a sixth criterionidentifying a minimum time since the patient began to exhale, a seventhcriterion identifying a minimum flow, an eighth criterion identifying amaximum pressure variation within the window, or a ninth criterionidentifying a maximum flow variation within the window.
 43. A method fordetermining leakage from a respiratory gas supply system, therespiratory gas supply system having a controller adapted for providingrespiratory gases to a breathing patient, comprising: identifying, bythe controller, at least one stable period within a breath of a patient;calculating leakage information from data indicative of one of pressureor flow obtained during the at least one stable period; subsequent tothe at least one stable period, estimating, by the controller, leakagefrom the respiratory gas supply system based on the leakage informationand current data indicative of one of pressure or flow; and adjusting atleast one of a pressure or a flow delivered to the patient based on theestimated leakage.
 44. The method of claim 43, wherein calculating theleakage information further comprises: calculating a net leakage fromthe respiratory gas supply system during the at least one stable periodbased on measurements of flow to the patient and flow exiting therespiratory gas supply system.